Morphologic and Biomechanical Analysis of the Carpal Ligaments

Joint Instability Clinical Trial

— EDLIS  

Official title:

Morphologic and Biomechanical Analysis of the Carpal Ligaments: a Kinematic Study on Dynamic Area Detector CT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02401568
• Other study ID #: 2014-A00845-42
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2015
• Last updated: March 7, 2016
• Start date: February 2015
• Est. completion date: February 2019

Study information

• Verified date: March 2016
• Source: Central Hospital, Nancy, France
• Contact: Pedro Gondim Teixeira, MD, PhD
• Phone: 0033 3 83 85 21 61
• Email: ped_gt[@]hotmail.com
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Compare various dynamic biomechanical markers (distances and angles) in the wrist during dynamic CT studies in three groups of patients: Normal subjects, with scapholunate instability and with other types of wrist instability.

Description:

Patients referred for the evaluation of wrist pain with CT arthrography will be eligible for inclusion. Patients will benefit from dynamic CT acquisitions before and after arthrography with three maneuvers: radio-ulnar deviation, clenching fist and dart throwing motion. Patients will also benefit from a wrist MR study on a 3 tesla scanner.

The morphology of the carpal ligaments will be evaluated on static imaging (MR and CT arthrograph) and on dynamic CT arthrography.

Distance and angular measurements will be obtained from dynamic CT studies using an appropriate post processing tool (4D-Ortho).

Data obtained with dynamic wrist evaluation will be correlated to ligament morphology, classical wrist instability criteria on conventional radiographs and with surgery (if available).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical signs of wrist instability or wrist pain

• Previous medical examination

• Informed consent

• Must have a social security number

Exclusion Criteria:

• MR or CT contra-indications

• No prior surgery

• Pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Joint Instability
• Wrist Injuries

Intervention

Device:
• Dynamic CT
Various low dose CT acquisitions will be successively performed on the wrist to allow a four dimensional evaluation. The same type of acquisition will be performed during various manoeuvers (radio-ulnar deviation, clenching fist, and dart-throwing motion).

Procedure:
• Arthrography
percutaneous intra-articular injection of contrast media in the medio-carpal and radio-carpal joints

Locations

Country	Name	City	State
France	CentralHNF	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (4)

Garcia-Elias M, Alomar Serrallach X, Monill Serra J. Dart-throwing motion in patients with scapholunate instability: a dynamic four-dimensional computed tomography study. J Hand Surg Eur Vol. 2014 May;39(4):346-52. doi: 10.1177/1753193413484630. Epub 2013 — View Citation

Gondim Teixeira PA, Gervaise A, Louis M, Lecocq S, Raymond A, Aptel S, Blum A. Musculoskeletal wide detector CT: principles, techniques and applications in clinical practice and research. Eur J Radiol. 2015 May;84(5):892-900. doi: 10.1016/j.ejrad.2014.12. — View Citation

Halpenny D, Courtney K, Torreggiani WC. Dynamic four-dimensional 320 section CT and carpal bone injury - a description of a novel technique to diagnose scapholunate instability. Clin Radiol. 2012 Feb;67(2):185-7. doi: 10.1016/j.crad.2011.10.002. Epub 2011 — View Citation

Troupis JM, Amis B. Four-dimensional computed tomography and trigger lunate syndrome. J Comput Assist Tomogr. 2013 Jul-Aug;37(4):639-43. doi: 10.1097/RCT.0b013e31828b68ec. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scapholunate diastasis (mm)	The distance between the scaphoid bone and the lunate bone will be measured during all maneuvers performed	1 day	No
Primary	Scapholunate angle	the variation in the scapholunate angle during the maneuvers performed will be assessed	1 day	No
Primary	Lunocapitate angle	the variation in the lunocapitate angle during the maneuvers performed will be assessed	1 day	No
Primary	Posterior radio scaphoid angle	The angle formed between the posterior most point of the scaphoid in the sagittal plane and the ventral and dorsal rims of the distal radius will be assessed	1 Day	No